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Completed

NCT Number: NCT00240643

Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke

This study will allow determination of the pharmacokinetic and pharmacodynamics of SB424323 in a relevant population. The data from this study will be used along with other data to aid in choosing the most appropriate dose for the later phase study.

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Key information

Conditions

Fibrillation, Atrial Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Buenos Aires, Argentina

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About this study

A randomized, double blind, double dummy, parallel group, placebo controlled study to evaluate the pharmacodynamic and pharmacokinetic response and safety and tolerability of SB424323 (250 mg, 375 mg and 500 mg) administered twice daily for 16 weeks, on top of aspirin (325 mg, qd) in men and women with non valvular atrial fibrillation at a low or intermediate risk for stroke

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with non valvular atrial fibrillation and any of the following:
  • </= 60 years old with no heart disease.
  • 60 years old with heart disease but no risk factors.
  • >/=60 years old and </=75 years old with no risk factors and no heart disease.
  • Must be able to take aspirin.

Exclusion criteria

  • Previous heart attack or stroke.
  • History of high blood pressure, diabetes or a prior blood clot.
  • Liver or kidney disease.
  • Need for anti-thrombotic or anti-platelet drugs.
  • Need for cardiovascular medicines.

Treatment and study plan

SB424323

Drug

Primary outcomes

  1. Relationship between anti IIa (a biomarker)and the dose of SB424323.

Secondary outcomes

  1. Blood levels of SB424323 during the study. Number of strokes, transient ischemic attacks or systemic embolism during the study. Changes in laboratory tests during the study.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomized, Double Blind, Double Dummy, Parallel Group, Placebo Controlled Study to Evaluate the Pharmacodynamic and Pharmacokinetic Response and Safety and Tolerability of SB424323 (250mg, 375mg and 500 mg) Administered Twice Daily for 16 Weeks, on Top of Asprin (325mg, qd) in Men and Women With Non Valvular Atrial Fibrillation at a Low or Intermediate Risk for Stroke

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 18, 2005
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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